PCI guidance with intravascular imaging, compared with angiography was associated with a sustained risk reduction for the primary composite endpoint of target vessel failure in patients with complex coronary artery lesions, according to results from the extended follow-up of the RENOVATE-COMPLEX-PCI study published March 4 in JACC.

In the multicenter open-label superiority trial, Joo Myung Lee, MD, MPH, PhD, FACC, et al., randomized 1,639 patients (mean age 66; 20% women) with complex coronary artery lesions across 20 hospitals in South Korea 2:1 to either intravascular imaging-guided PCI (n=1,092) or angiography-guided PCI (n=547). Of the overall cohort, 49% presented with stable ischemic heart disease and 51% with an acute coronary syndrome (ACS). Thirty-one percent had three or more characteristics of complex coronary artery lesions in the target lesion. The most common was long coronary lesion, followed by multivessel PCI, true bifurcation lesion and chronic total occlusion.

Stent optimization was achieved in 45% of patients in the intravascular imaging arm and 59% of those in the angiographic arm. Procedural time was about 15 minutes longer in the intravascular imaging arm, and both arms had similar rates of procedure-related complications during the index hospitalization.

Long-term results at a median follow-up of 5.3 years showed that the primary endpoint – a composite of cardiac death, target vessel-related myocardial infarction (MI) or clinically driven target vessel revascularization (TVR) – occurred in 109 patients (10.5%) in the intravascular imaging arm vs. 78 (14.9%) in the angiography arm (hazard ratio 0.68; p=0.009).

Looking at the secondary endpoints, in the intravascular imaging and angiography arms respectively, cardiac death or target vessel-related MI occurred in 7.6% vs. 10.7% of patients, clinically driven TVR in 4.4% vs. 6.2% and definite stent thrombosis in 0.1% vs. 0.7% of patients.

There was a consistent benefit across most prespecified clinical subgroups, with intravascular imaging providing the greatest benefit over angiography in chronic total occlusion and diffuse long lesion. Patients with stable ischemic heart disease appeared to have a greater benefit than those with ACS, although there was no interaction between outcomes and clinical presentation.

The authors write that their landmark analysis at two years “presented the earlier prognostic benefit of intravascular imaging-guided PCI” and that this benefit “was maintained through later periods of follow-up without late catch-up phenomenon.” They conclude that their “trial supports the use of intravascular imaging-guided PCI to improve long-term clinical outcomes of patients with complex coronary artery lesions.”

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